Drug product
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
D-1063-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7656 syringes
- Official record key
drug-enforcement:D-1063-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 10099, BUD: 7/27/2017; 10127, BUD: 8/1/2017; 10208, BUD: 8/10/2017; 10254, BUD: 8/15/2017; 10278, BUD: 8/17/2017; 10303, BUD: 8/21/2017; 10371, BUD: 9/3/2017; 10457, BUD: 9/17/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility